VERION Versus Conventional, Manual Ink-marking in Toric IOL Implantation

NACompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

January 31, 2016

Study Completion Date

February 29, 2016

Conditions
Astigmatism
Interventions
DEVICE

VERION for toric IOL alignment

The VERION Measurement Module is a diagnostic device which can make high resolution colour reference images of the patient's eye for position reference. The VERION Digital Marker is a medical device that assists the surgeon in planning and performing surgical procedures on the eye. The VERION tools use several reference points on the conjunctiva and limbus, and make an overlay between the preoperative achieved and live-surgery image. During surgery, this device projects the horizontal axis and the estimated placement axis of the toric IOL on the patient's eye, and therefore, the surgeon can accurately place the toric IOL to its preoperatively calculated angle.

PROCEDURE

Conventional, manual ink-marking for toric IOL alignment

Several manually performed methods are used to align the toric IOL at the intended axis. Most of them use a 3-step procedure. First, the horizontal axis of the eye is temporarily marked with ink in a seated position to correct for cyclotorsion when changing into supine position. Three spots on the conjunctiva, close to the edge of the cornea, are applied at 0°, 90° and 180°, which may be done by using a bubblemarker or gravity marker with a calibrated horizontal position. Next, the desired alignment axis for the toric IOL is marked intra-operatively. The last step is to rotate the implanted toric IOL until the IOL markings agree with the alignment marks. After surgery is performed, the ink marks will disappear within a few hours.

Trial Locations (1)

6202 AZ

Maastricht University Medical Centre, Maastricht

All Listed Sponsors
lead

Maastricht University Medical Center

OTHER

NCT02370953 - VERION Versus Conventional, Manual Ink-marking in Toric IOL Implantation | Biotech Hunter | Biotech Hunter